Complication, COVID-19, COVID-19 Pneumonia, Death, Hospitalization, Outpatient, Proning
Conditions
Brief summary
The rapid development of safe and effective COVID-19 treatment is a global health priority. Numerous studies evaluating therapies for this disease are currently underway, but the majority of these are in hospitalized patients with severe illness. Consequently, there is an urgent need to identify therapies that prevent mild COVID-19 cases in the community from becoming more severe. Proning or lying face down in bed has been shown to improve breathing and oxygen levels in COVID-19 patients, reducing the need for breathing tubes and ventilators and increasing survival. The current study will investigate whether proning and repositioning (lying on one's side or sitting up) can prevent mild cases of COVID-19 from becoming more severe resulting in fewer hospitalizations and death. A randomized controlled trial will be used to reduce the risk of bias when testing this intervention. Unvaccinated or partially vaccinated adult patients with a positive COVID-19 test willing to participate and well enough to be treated outside the hospital will be randomly assigned to one of two groups: a home-proning intervention group with instructions and daily reminders to prone and reposition during the day and at night, and a standard care group. Our goal is to assess whether home-proning/repositioning leads to fewer hospitalizations and death when compared with standard care. We'll also compare recovery time, use of antibiotics and follow up emergency department visits between these two groups. The current pilot study will assess the feasibility of a larger investigation or main trial, meaning it will be small scale test of methods and procedures to be used on a larger scale.
Interventions
OTHERSelf-proning
Rotating between lying flat with the chest down, on one's side or sitting up every 30 minutes to 2 hours when lying down during the day or while sleeping at night.
Sponsors
Applied Health Research Centre
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label, pragmatic, randomized controlled internal pilot trial (vanguard phase)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Positive SARS-CoV-2 PCR test 3. Presence of two or more of the following criteria: 1. Age\>55 years 2. Fever by history or at presentation 3. Cough 4. Dyspnea/shortness of breath 5. Fatigue necessitating daytime bed rest 6. One or more of the following medical conditions: * Hypertension * Diabetes * Cardiovascular disease * Chronic lung disease * Chronic kidney disease * Obesity (BMI≥30kg/m2) 7. Tachycardia \> 110 bpm 8. Oxygen saturation \<94% 9. One or more of the following laboratory abnormalities: * Lymphocytes \<1500/microL * ESR \> 100 mm/h * CRP \> 10 mg/L * D-Dimer \> 1000 ng/mL * LDH \> 240 U/L 10. Bilateral infiltrates or ground glass opacities on chest x-ray or CT scan 4. Socially and medically fit for discharge 5. Access to a smartphone
Exclusion criteria
1. Pregnancy \>20/40 weeks 2. Body mass index (BMI) \>40 kg/m2. 3. Skeletal deformities that interfere with proning 4. Developmental delay or cognitive impairment that would preclude patient cooperation 5. Other contraindications to proning including any of the following: recent abdominal surgery, active vomiting, acute intoxication. 6. Unlikely to adhere to the proning protocol according to the treating physician's judgment 7. Fully vaccinated for COVID-19
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of hospitalization and all cause mortality | Up to 28 days post-randomization | The primary outcome is a composite of hospital admission and all-cause mortality. This will be ascertained using telephone follow up and deterministic record linkage performed by the Institute for Clinical Evaluative Sciences (ICES) using their Discharge Abstract Database (DAD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | Up to 28 days post-randomization | — |
| Time to functional recovery in days | Up to 28 days post-randomization | Defined as: resolution of fever for 48 hours, significant symptom reduction and ability to perform most daily activities or return to work, if applicable, for two consecutive days. |
| Use of antibiotics for respiratory illness | Up to 28 days post-randomization | — |
| Follow up emergency department assessment without hospital admission | Up to 28 days post-randomization | Number of subsequent emergency department visits by study participants that relate to the initial COVID-19 presentation but do not result in hospital admission |
| Hospitalization | Up to 28 days post-randomization | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility outcome: adherence to the intervention | Up to 28 days | Defined as self-proning and repositioning daily for \>=75% of days of symptom duration. Adherence will be ascertained through daily survey of study participants. |
| Feasibility outcome: successful retention of trial participants, | Up to 28 days | Defined as \<10% attrition rate |
| Feasibility outcome: successful recruitment | Through study completion, on average one year | Defined as \>=50% of eligible participants agreeing to enrollment |
Countries
Canada
Outcome results
None listed